Container Closure Integrity Test Bacterial
The Container Closure Integrity test evaluates the adequacy of the closure in maintaining a sterile barrier. This test is performed on products such as filled vials, syringes and devices. PDA Technical Report 27 recommends both a physical and microbial test when evaluating container closure integrity for pharmaceutical packaging.
This test satisfies a worst-case scenario for the microbial recommendation and meets the requirements described in the FDA’s “Container Closure Systems for Packaging for Human Drugs and Biologics.” Nelson Laboratories performs this test using a unique chamber that allows us to apply pressure and/or vacuum to the challenge solution and test samples.
Interested in the Container Closure Integrity by Dye Immersion test?
- USP <1207>
- PDA TR 27
- FDA Docket 980-0021
Ask an expert for a specific consultation on your product. If you are ready to submit your samples for testing, click here to fill out the Sample Submission Form.
|PKG410||Packaging: Container Closure Integrity, Bacterial Immersion||Add|
|PKG411||Packaging Container Closure Integrity: Bacterial Immersion Sensitivity||Add|
PKG410 - Packaging: Container Closure Integrity, Bacterial Immersion
PKG411 - Packaging Container Closure Integrity: Bacterial Immersion Sensitivity
PKG410: Number of test containers determined by the sponsor + 9 controls (3 bacteriostasis (included in pricing), 3 negatives and 3 positives)
Study OutlineThe purpose of the Container Closure Integrity test is to evaluate the barrier properties of filled vials and closed systems. The samples are tested by immersing media-filled containers into a microbial challenge for a specified amount of time using pressure and vacuum. The containers are then removed from the challenge, rinsed, incubated and examined for growth. A bacteriostasis test is performed concurrent with the test or at the end of the 7-day incubation. Controls are performed with each challenge.
The selection of B. diminuta as the challenge organism is based on its very small size when grown under carefully controlled conditions. Due to its size, B. diminuta represents a most severe bacterial challenge. Other organisms may also be selected. The high concentration in microbiological challenge adds to the worst-case conditions for testing.
Samples must arrive sterile if filled by the sponsor.
B. diminuta is an aerobic organism so it is recommended, when filling test samples, to allow for an air headspace of ≥50% of the total volume of the container, if possible.